Canada - Biosafety advisory: Avian influenza A(H5N1) (PHAC, CFIA, June 28, 2024)

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Biosafety advisory: Avian influenza A(H5N1)

On this page

• 1.0 Background
• 2.0 Authorization requirements
  • 2.1 Authorization issued by the Public Health Agency of Canada
  • 2.2 Authorization issued by the Canadian Food Inspection Agency
• 3.0 Disease reporting requirements
• 4.0 Biosafety recommendations for non-propagative diagnostic and surveillance activities
  • 4.1 Human primary specimens as they relate to the Human Pathogens and Toxins Act and Regulations
  • 4.2 Domestically acquired animal and environmental specimens not suspected to contain avian influenza A(H5N1) as they relate to the Health of Animals Act and Regulations
• 5.0 Biosafety requirements for diagnostic, surveillance, in vitro, and in vivo activities
  • 5.1 Containment level requirements
• 6.0 Animal work considerations
• 7.0 Transportation as it relates to the Transportation of Dangerous Goods Regulations
• 8.0 Contact information
• 9.0 References and resources

This Biosafety Advisory is being provided by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA). Its purpose is to assist surveillance, clinical, diagnostic, and research facilities in implementing proper biosafety procedures to mitigate the risks associated with handling materials that may contain Alphainfluenzavirus influenzae H5N1 (avian influenza A[H5N1]). This Advisory provides information specific to avian influenza A(H5N1) to supplement the requirements and recommendations for working with new and emerging influenza A viruses described in the Biosafety Directive for New and Emerging Influenza A Viruses.

The regulatory oversight of avian influenza A(H5N1) virus is under the authority of PHAC and CFIA. Avian influenza A(H5N1) is classified as a Risk Group 3 (RG3) human pathogen. It is a prescribed pathogen, also referred to as a security sensitive biological agent (SSBA), under Section 10 of the Human Pathogens and Toxins Regulations (HPTR). Additionally, avian influenza A(H5N1) is classified as an RG3 animal pathogen and a foreign animal disease (FAD) agent, making it a CFIA-Designated Terrestrial Animal Pathogen (CD-TAP).

This Biosafety Advisory is based on the scientific evidence available as of its publication date and is subject to revisions as new information becomes available.

1.0 Background


Alphainfluenzavirus influenzae H5N1 (avian influenza A[H5N1]) is a highly pathogenic avian influenza (HPAI) virus that emerged in Southern China in 1996.^Footnote1 The first cases of avian influenza A(H5N1) disease in humans were recorded in 1997 in Hong Kong, at the same time as outbreaks in farmed poultry.^{Footnote2 Footnote3 Footnote4} Since then, sporadic human infections have been reported around the world, including in Southeast Asia, the Middle East, North Africa, the United Kingdom, and the United States. From 2003 to May 2024, 889 human cases and 463 deaths have been confirmed by the World Health Organization (WHO).^Footnote5 Avian influenza A(H5N1) has the capacity to cause severe disease and death in healthy individuals with no pre-existing medical conditions.

Avian influenza A(H5N1) circulates in wild birds globally, which results in genetic divergence and distinct clades and subclades in different geographic areas.^{Footnote6 Footnote7} Clade 2.3.4.4b is the predominant avian influenza A(H5N1) strain that has been responsible for global outbreaks in wild birds since October 2021.^Footnote8 While most avian influenza A strains transmit asymptomatically through wild bird populations and cause mild disease in farmed poultry, avian influenza A(H5N1) clade 2.3.4.4b has caused a significant increase in the number of wild bird deaths and outbreaks in farmed poultry worldwide.^{Footnote9 Footnote10}

Avian influenza A(H5N1) infections have been reported in dairy cattle, as well as in cats, dogs, neonatal goats sharing single premises with poultry, and other mammalian species (e.g., mink, sea lions, seals, raccoons, skunks, foxes).^{Footnote9 Footnote11} This diversification and spillover of avian influenza A(H5N1) from wild birds into mammals increases opportunities for genetic change that could result in a virus with greater fitness in mammalian hosts, including humans.^Footnote12 The spillover into mammals also increases the opportunity of transmission to humans who have close contact with infected animals and associated environments, especially if infections are mild or asymptomatic and mitigation measures have not been implemented.

Avian influenza A viruses with haemagglutinin subtype H5 have historically resulted in limited animal-to-human transmission, and currently no human-to-human transmission has been reported.^{Footnote12 Footnote13} Animal-to-human transmission of avian influenza A(H5N1) has occurred from exposure to infected dairy cattle, infected poultry, and contaminated environments. From early 2021 to April 2024, most human cases of avian influenza A(H5N1) reported to WHO were associated with outbreak response activities or direct exposure to infected animals or environments.^Footnote9 Fifty-four percent (54%) of these infections in humans with a known clade were caused by clade 2.3.4.4b.

It is important to be vigilant for avian influenza A(H5N1) strains that are transmitted within and between species including livestock, wildlife, and humans, as pandemics have historically emerged due to reassortment of animal and human influenza viruses.^Footnote14 Nonetheless, the possibility of a future pandemic triggered by a novel, wholly avian virus without reassortment cannot be excluded. A novel avian influenza A(H5N1) strain associated with sustained human-to-human transmission and significantly higher mortality than seasonal influenza could have a serious impact on public health and healthcare facilities.

2.0 Authorization requirements


Avian influenza A(H5N1) is classified as an RG3 human and animal pathogen, as well as an SSBA and a CD-TAP. As a result, it is regulated under both the Human Pathogens and Toxins Act (HPTA) and the Health of Animals Act (HAA) and their Regulations.^{Footnote15 Footnote16} Regulated samples of avian influenza A(H5N1) must be handled and stored in a facility that meets the minimum applicable biosafety and biosecurity requirements specified in Sections 3, 4, and 5 of the Canadian Biosafety Standard (CBS), Third Edition.^Footnote17 Regulatory requirements are determined based on sample and activity type, and on whether material that may contain avian influenza A(H5N1) is imported. Please refer to section 5.1 of the Advisory to determine which containment level requirements apply.

Facilities where avian influenza A(H5N1) is handled or stored require authorization from both PHAC and CFIA. For contact information for PHAC and CFIA, please refer to section 8.0

. 2.1 Authorization issued by the Public Health Agency of Canada

RG3 SSBA Pathogen and Toxin Licence issued under the HPTA


Unless otherwise excluded or exempted, a Pathogen and Toxin Licence issued by PHAC under the HPTA is required to conduct controlled activities with avian influenza A(H5N1), as defined in Section 7 of the HPTA.^{Footnote15 Footnote18 Footnote19}

Security Clearance issued under Section 33 of the HPTA


In accordance with Section 33 of the HPTA, a valid HPTA Security Clearance is required to enter an area where avian influenza A(H5N1) is handled and stored as this pathogen is an SSBA. Individuals who do not hold an HPTA Security Clearance must always be accompanied and supervised, in a 1 to 1 ratio, by an individual who holds a valid HPTA Security Clearance. An individual is not required to hold an HPTA Security Clearance if avian influenza A(H5N1) is locked up and inaccessible to that individual [HPTR 28(b)].

Laboratory analyses and diagnostic activities with primary specimens that may contain avian influenza A(H5N1) do not require an HPTA Security Clearance. However, knowingly culturing or intentionally collecting or extracting avian influenza A(H5N1) from primary specimens requires an HPTA Security Clearance.

Note that there needs to be at least one valid HPTA Security Clearance holder employed at the facility for an RG3 SSBA Pathogen and Toxin Licence to be issued by PHAC. Please refer to PHAC's website for more information on SSBAs and the HPTA Security Clearance program, as well as associated Service Standards.^{Footnote20 Footnote21 Footnote22}

2.2 Authorization issued by the Canadian Food Inspection Agency


The Animal Pathogen Import Permit, Animal Pathogen Transfer Permit, or Quarantine Order issued by CFIA specifies conditions to be respected, including the type of activities permitted, the containment level requirements, and any additional biosafety requirements to be followed. Moreover, for such regulatory documents to be issued, facilities must hold a valid CFIA Facility Compliance Letter or Facility Certification Letter.

Animal Pathogen Import Permit for imported material issued under Section 51 of the HAR


An Animal Pathogen Import Permit is required to import:

• pure cultures or isolates of avian influenza A(H5N1)
• biological materials (e.g., quality control samples, proficiency panels, vaccine candidates) containing avian influenza A(H5N1)
• animal primary specimens or samples (e.g., tissue, serum, blood), animal products or by-products (e.g., milk), or environmental samples associated with animals (e.g., animal pen bedding) that:
  • may, but are unlikely to, contain avian influenza A(H5N1)
  • are suspected or confirmed to contain avian influenza A(H5N1)
• any other type of specimens, such as a human primary specimen or environmental sample not associated with animals (e.g., swab of a hospital surface, air sample from a school), that:
  • may, but are unlikely to, contain avian influenza A(H5N1)
  • are suspected or confirmed to contain avian influenza A(H5N1)

Animal Pathogen Transfer Permit for imported material issued under Section 51 of the HAR


An Animal Pathogen Transfer Permit is required to transfer any imported material or its derivatives containing avian influenza A(H5N1) to a location other than that specified on the Animal Pathogen Import Permit.

Quarantine Order for domestically acquired (i.e., non-imported) material issued under Section 91.4 of the HAR


A Quarantine Order may be issued upon either:

• reporting avian influenza A(H5N1) to CFIA following its suspicion, detection, or diagnosis in an animal, an animal primary specimen or sample (e.g., tissue, serum, blood), an animal product or by-product (e.g., milk), or an environmental sample associated with an animal (e.g., animal pen bedding) if the domestically acquired virus is intended to be kept in the facility; or
• domestically acquiring any material (e.g., human primary sample, environmental sample not associated with animals) confirmed to contain avian influenza A(H5N1) and with which work is intended to be performed in the facility beyond human, animal, or environmental surveillance and diagnostic activities (e.g., research activities with live virus, human or animal vaccine development work, propagative in vitro activities, in vivo activities).

3.0 Disease reporting requirements


Provincial and territorial public health authorities must report confirmed and probable human cases of avian influenza A(H5N1) to PHAC within 24 hours of their own notification. PHAC strongly encourages the immediate notification of such cases to provincial and territorial public health authorities. For information on investigating human cases of avian influenza A(H5N1), please consult the Protocol for Microbiological Investigations of Severe Acute Respiratory Infections (SARI) and Avian influenza A(H5N1): For health professionals.^{Footnote23 Footnote24}

If avian influenza A(H5N1) is suspected, detected, or diagnosed in an animal, an animal primary specimen or sample, an animal product or by-product, or an environmental sample associated with an animal, it must be immediately reported to a CFIA district veterinarian.^Footnote25 Avian influenza A(H5N1) is a federally reportable disease under the HAA and Reportable Disease Regulations.^Footnote26 Reportable diseases can impact human health, animal health, and the Canadian economy and are to be reported to CFIA by animal owners, veterinarians, laboratories, and any person with care or control of animals. Please consult CFIA's website on Avian influenza (bird flu) for additional information.^Footnote27

4.0 Biosafety recommendations for non-propagative diagnostic and surveillance activities

4.1 Human primary specimens as they relate to the Human Pathogens and Toxins Act and Regulations


A pathogen in a primary specimen (i.e., in its natural environment) is excluded from the HPTA and is therefore not regulated by PHAC if the pathogen has not been intentionally cultivated, collected, or extracted (e.g., concentrated, cultured).^Footnote18 Primary specimens will generally contain lower concentrations of pathogens than found in cultures (i.e., propagated pathogens). Examples of primary specimens include nasopharyngeal swabs, respiratory specimens (e.g., sputum), blood, plasma, feces, and tissues collected directly from patients.

Although non-propagative diagnostic activities with primary specimens are excluded from the HPTA, PHAC recommends that personnel performing these activities with primary specimens that may contain pathogens follow the operational practices described in Chapter 4 of the Canadian Biosafety Guideline - Human Diagnostic Activities.^Footnote28 In addition, PHAC generally recommends that human primary specimens be handled as though they contain, at minimum, an RG2 pathogen, and that facilities where they are handled meet the minimum operational requirements for CL2 specified in Section 4 of the CBS.

As avian influenza A(H5N1) is an RG3 pathogen, PHAC strongly recommends that diagnostic facilities where non-propagative activities are performed with human primary specimens that may contain avian influenza A(H5N1) meet, at minimum, the:

• physical containment, operational practice, and performance and verification testing requirements for CL2 laboratory work areas as detailed in the CBS; and
• additional operational practices detailed in the Biosafety Directive for New and Emerging Influenza A Viruses.^Footnote29

Additionally, PHAC strongly recommends that if a human diagnostic facility detects a non-negative primary specimen (i.e., tests positive for avian influenza A[H5N1]), the non-negative primary specimen is transferred to a facility that holds an RG3 SSBA Pathogen and Toxin Licence or the National Microbiology Laboratory (NML) for confirmatory testing and any further handling. Contact information for the NML Viral Diseases section can be found in the NML Guide to services.^Footnote30

As described in the Canadian Biosafety Guideline - Human Diagnostic Activities, facilities are strongly encouraged to conduct a local risk assessment (LRA) for diagnostic activities, taking into consideration the potential for infectious aerosol and droplet production and the risk of exposure.^Footnote28 This will assist in determining appropriate mitigation measures that reduce site-specific and activity-specific risks. Examples of non-propagative diagnostic activities that may result in the production of aerosols include the preparation of samples for biochemical assays (e.g., enzyme-linked immunosorbent assay [ELISA]), preparation of samples for polymerase chain reaction (PCR), and preparation of frozen sections (unfixed tissues) with a cryostat. Best practices for conducting an LRA can be found in the Canadian Biosafety Guideline - Local Risk Assessment.^Footnote31

In the context of this Biosafety Advisory, it is recommended that diagnostic facilities where non-propagative activities with human primary specimens that may contain avian influenza A(H5N1) are conducted take additional risk mitigation measures. These include, but are not limited to:

• Donning an additional layer of personal protective equipment (PPE) (e.g., gloves, face shield) when performing certain activities (e.g., handling primary specimens that are suspected to contain avian influenza A[H5N1]).
• Leaving personal belongings and other items for personal use (e.g., purse, cell phone) outside of areas where activities with avian influenza A(H5N1) may be conducted, as influenza A viruses can survive on surfaces for several hours and in aerosols for up to 24 hours. This measure protects individuals from exposure and prevents the spread of influenza A viruses.
• Considering the prevalence of influenza A in the patient population being served when selecting PPE. For example, donning additional PPE when collecting samples from individuals that have had contact with avian influenza A(H5N1)-infected animals.

To prevent exposure to, or release of avian influenza A(H5N1) aerosols, it is recommended that:

• Activities involving open vessels of primary specimens that are suspected or confirmed to contain avian influenza A(H5N1) are performed in a biological safety cabinet (BSC) or other primary containment device.
• Centrifugation of primary specimens that are suspected or confirmed to contain avian influenza A(H5N1) are carried out in sealed safety cups or rotors and unloaded in a BSC.

4.2 Domestically acquired animal and environmental specimens not suspected to contain avian influenza A(H5N1) as they relate to the Health of Animals Act and Regulations


Non-propagative surveillance and diagnostic activities with domestically acquired (i.e., non-imported) primary animal specimens or environmental samples associated with animals (e.g., animal pen bedding) that are not suspected to contain avian influenza A(H5N1) are not regulated under the HAA/R. However, as avian influenza A(H5N1) is an RG3 pathogen, CFIA strongly recommends these activities occur in a facility that, at minimum, meets the:

• physical containment, operational practice, and performance and verification testing requirements for CL2 laboratory work areas as detailed in the CBS; and
• additional operational practices detailed in the Biosafety Directive for New and Emerging Influenza A Viruses.^Footnote29

5.0 Biosafety requirements for diagnostic, surveillance, in vitro, and in vivo activities


All facilities where imported or domestically acquired avian influenza A(H5N1) is suspected or confirmed to be present must comply with the applicable biosafety and containment requirements for their activity and specimen type:

• Facilities where activities are conducted with any imported materials or their derivatives must follow the requirements outlined in section 5.1 and adhere to the CFIA authorization requirements in section 2.2. This applies to imported materials that:
  • may, but are unlikely to, contain avian influenza A(H5N1)
  • are suspected or confirmed to contain avian influenza A(H5N1)
• Facilities where activities are conducted with domestically acquired primary animal specimens or environmental samples associated with animals suspected or confirmed to contain avian influenza A(H5N1) must follow the requirements outlined in section 5.1.
• Moreover, facilities where any material containing avian influenza A(H5N1) is domestically acquired with the intent to perform work beyond surveillance and diagnostic activities must follow the requirements outlined in section 5.1. Activities with domestically acquired avian influenza A(H5N1) may be subject to a Quarantine Order issued by CFIA, as detailed in section 2.2.
• If a veterinary diagnostic laboratory detects a non-negative sample (i.e., tests positive for avian influenza A[H5N1]), all work with the sample must be stopped. This sample is to be transferred to the National Centre for Foreign Animal Disease (NCFAD) in Winnipeg for confirmatory testing. Detection of a non-negative sample must be reported to CFIA as per section 3.0, Disease reporting requirements.

5.1 Containment level requirements


As avian influenza A(H5N1) is an RG3 human and animal pathogen, an SSBA, and a CD-TAP, strict containment requirements must be met to reduce the risks of exposure to it and its release. Table 1 summarizes the minimum containment level requirements for facilities where avian influenza A(H5N1) is handled or stored.

Non-propagative activities (i.e., diagnostic and surveillance activities) Applicable to any imported materials or their derivatives that may, but are unlikely to, contain avian influenza A(H5N1) and are regulated under the HAR. Materials include human primary specimens, animal primary specimens, environmental samples, and animal products and by-products. Examples of activities include, but are not limited to: handling applicable specimen types performing antigen testing, nucleic acid extraction and testing, rapid molecular assays for the purpose of diagnosing or monitoring an infection, and genetic sequencing centrifuging primary specimens without the intent to pellet avian influenza A(H5N1) (e.g., to separate plasma) performing clinical chemistry studies, urinalysis, and hematology and serology testing (e.g., analysis with automated platforms) preparing applicable specimen types for packaging and shipping to diagnostic laboratories for additional testing performing routine staining and microscopic analysis of applicable specimen types using positive controls containing non-viable avian influenza A(H5N1)	CL2 with additional operational practicesFootnote1	CFIA
Non-propagative in vitro activities Applicable to materials regulated under the HAR that are suspected to contain avian influenza A(H5N1), which includes: any imported material including human primary specimens, animal primary specimens, environmental samples, or animal products and by-products domestically acquired primary animal specimens, environmental samples associated with animals, or animal products or by-products AND Applicable to any imported or domestically acquired materials confirmed to contain avian influenza A(H5N1) and regulated under the HAR. Examples of activities include, but are not limited to: handling applicable materials with the intent to perform work beyond surveillance and diagnostic activities handling applicable materials suspected to contain viable avian influenza A(H5N1)	CL3	CFIA
Non-propagative and propagative in vitro activities Applicable to materials with concentrated or propagated avian influenza A(H5N1) virus. Examples of activities include, but are not limited to: knowingly concentrating or isolating avian influenza A(H5N1) from primary specimens or environmental samples (e.g., ultracentrifugation) with the intent to propagate the virus or conduct research activities handling materials containing viable avian influenza A(H5N1), including positive controls containing propagated live virus performing diagnostic activities that require culturing avian influenza A(H5N1) or diagnostic tests that require live propagated virus (e.g., hemagglutination test, serum neutralization test) culturing avian influenza A(H5N1) for research purposes (e.g., propagating the virus) preparing avian influenza A(H5N1) virus cultures for packaging and shipping to a regulated facility carrying out preparatory work for in vivo activities	CL3	CFIA, PHAC
In vivo activities Applicable to experimentally infected animals. Examples of activities include, but are not limited to: inoculating animals housing infected animals collecting and processing specimens from infected animals (e.g., nasal or throat swab, blood, bronchial lavage)	CL3Footnote2	CFIA, PHAC
Footnote 1 CL2 with additional operational practices as outlined in the Biosafety Directive for New and Emerging Influenza A Viruses. Return to footnote1referrer Footnote 2 Work in small animal containment zones (SA zones) must meet the applicable requirements in the CL3 column of the CBS, whereas work in large animal containment zones (LA zones) must meet the applicable requirements in the CL3-Ag column of the CBS. Return to footnote2referrer

Many of the CBS requirements are risk- and performance-based and, as such, require facilities to conduct an LRA to determine if additional biosafety measures above the minimum containment level requirements are needed. As avian influenza A(H5N1) virus is classified as a CD-TAP, facilities also need to adhere to additional or more stringent requirements to prevent its release into the environment and the subsequent spread of the disease. These requirements are indicated in the CBS for non-indigenous terrestrial animal pathogens. 6.0 Animal work considerations


The primary route of animal-to-human transmission for influenza A viruses is through exposure of mucous membranes to excreta or secretions of infected birds.^Footnote32 However, transmission caused by inhalation of, or contact with avian influenza A(H5N1) virus particles in contaminated environments has also been reported. Thus, activities involving animals or potential exposure to infectious avian influenza A(H5N1) aerosols (e.g., handling animals, cleaning cages, entering a large animal cubicle) are performed with additional precautions.

These precautions may include, but are not limited to:

• Avoiding the direct handling of animals known or suspected to be infected with avian influenza A(H5N1) to minimize the risk of handler injury and exposure. When handling animals cannot be avoided, proper handling techniques, restraint equipment or chemical restraints (e.g., anaesthetics, immobilizing agents) are employed whenever possible.
• Wearing a respirator and additional face protection (e.g., face shield, goggles) when handling, or in the presence of animals known or suspected to be infected with avian influenza A(H5N1) or in a contaminated area (e.g., large animal cubicle).
• Using a primary containment device (e.g., BSC) and primary containment caging for small animals (e.g., rodents) known or suspected to be infected with avian influenza A(H5N1). Primary containment systems with high efficiency particulate air (HEPA) filtration minimize the potential release of avian influenza A(H5N1) virus particles.
• Wearing dedicated boots or shoe covers when working in contaminated areas where animals are present to prevent the spread of avian influenza A(H5N1) virus via infected animal excreta, secretions, or bedding.
• Following established exit procedures for CL3 or CL3-Ag facilities certified by CFIA for work with avian influenza A(H5N1).

7.0 Transportation as it relates to the Transportation of Dangerous Goods Regulations


For CFIA authorization requirements on importation and transfer, please refer to section 2.2.

The transportation of avian influenza A(H5N1) is subject to the Transportation of Dangerous Goods Regulations (TDGR) and must meet the packaging requirements stipulated in the standard CAN/CGSB-43.125.^{Footnote33 Footnote34} Of note, persons who handle, offer for transport, or transport dangerous goods must be adequately trained and hold a training certificate in accordance with Part 6 of the TDGR.

Avian influenza A(H5N1) is an infectious substance of Category A. Therefore, any material that contains avian influenza A(H5N1) (e.g., cultures) or may contain avian influenza A(H5N1) (e.g., primary specimens) is classified as a Category A infectious substance and is assigned to UN2814, INFECTIOUS SUBSTANCE, AFFECTING HUMANS, Class 6.2, Category A.

However, to facilitate patient care, whether human or animal:

• Patient specimens that contain or may contain avian influenza A(H5N1) may be assigned to UN3373, BIOLOGICAL SUBSTANCE, CATEGORY B, Class 6.2, Category B, and be transported as Category B in accordance with the conditions set out in Section 1.39 of the TDGR.^Footnote33 This does not apply if the patient specimen contains any Category A infectious substance listed in Subsection 2.36(3) of the TDGR, or any infectious substance exhibiting similar characteristics.^Footnote33
• Waste generated from patient care, or the collection or testing of patient specimens, that may contain avian influenza A(H5N1) may be assigned to UN3291 with one of the following shipping names: CLINICAL WASTE, UNSPECIFIED, N.O.S.; BIOMEDICAL WASTE, N.O.S.; MEDICAL WASTE, N.O.S.; or REGULATED MEDICAL WASTE, N.O.S. This does not apply if the waste contains any Category A infectious substance listed in Subsection 2.36(3) of the TDGR, or any infectious substance exhibiting similar characteristics.^Footnote33

Waste containing propagated or concentrated avian influenza A(H5N1) is assigned to UN2814, INFECTIOUS SUBSTANCE, AFFECTING HUMANS; or UN3549, MEDICAL WASTE, CATEGORY A, AFFECTING HUMANS, solid.

Materials that are not considered infectious as per the TDGR or that are exempt from the packaging requirements of the TDGR are still required to meet normal transportation conditions, such as leak-proof packaging. Please consult the TDGR if other infectious substances or other dangerous goods are present.

For more information, consult the Transport Canada Transportation of Dangerous Goods website or the Transport Canada Shipping Infectious Substances bulletin.^{Footnote35 Footnote36} To obtain further assistance, contact Transport Canada at:

• TDG-TMD@tc.gc.ca (for general inquiries)
• TDGMOC-TMDContenants@tc.gc.ca (for means of containment)
• TC.TDGClassification-ClassificationTMD.TC@tc.gc.ca (for classification)

In the event of an emergency involving dangerous goods, call CANUTEC at 1-888-CANUTEC (226-8832), 613-996-6666 or *666 on a cellular phone. 8.0 Contact information


Further biosafety information may be obtained by visiting the PHAC Centre for Biosecurity website or contacting PHAC by:

• email: pathogens.pathogenes@phac-aspc.gc.ca
• phone: 613-957-1779

For information on obtaining a Pathogen and Toxin Licence issued by PHAC, please visit the licensing program web page or contact licence.permis@phac-aspc.gc.ca.^{Footnote37 Footnote38}


For information on obtaining an Animal Pathogen Import Permit, Animal Pathogen Transfer Permit, or CL2 Facility Compliance Letter issued by CFIA, please contact 1-800-442-2342 or permission@inspection.gc.ca.

For information on CL3 facility certification by CFIA, please contact the Office of Biohazard Containment and Safety (OBCS) at biocon@inspection.gc.ca.

To report the presence, or suspected presence, of a reportable disease in or around animals to a CFIA district veterinarian, please Contact a CFIA Animal Health Local Office by Telephone.^Footnote25

9.0 References and resources

1 United States Centers for Disease Control and Prevention. (2022). Emergence and Evolution of H5N1. United States Centers for Disease Control and Prevention. Retrieved 2024-05-27 from https://www.cdc.gov/flu/pdf/avianflu...in-graphic.pdf

Return to footnote1referrer 2 Harada, Y., Ninomiya-Mori, A., Takahashi, Y., Shirakura, M., Kishida, N., Kageyama, T., Tada, Y., Tashiro, M., & Odagiri, T. (2011). Inactivated and Adjuvanted Whole-virion Clade 2.3.4 H5N1 Pre-Pandemic Influenza Vaccine Possesses Broad Protective Efficacy Against Infection by Heterologous Clades of Highly Pathogenic H5N1 Avian Influenza Virus in Mice. Vaccine, 29(46): 8330–8337.

Return to footnote2referrer 3 Hui, D. S. (2008). Review of Clinical Symptoms and Spectrum in Humans with Influenza A/H5N1 Infection. Respirology, 13(s1): s10-s13.

Return to footnote3referrer 4 Bridges, C. B., Katz, J. M., Seto, W. H., Chan, P. K. S., Tsang, D., et al. (2000). Risk of Influenza A (H5N1) Infection Among Health Care Workers Exposed to Patients with Influenza A (H5N1), Hong Kong. The Journal of Infectious Diseases, 181(1): 344-348.

Return to footnote4referrer 5 World Health Organization. (2024). Cumulative Number of Confirmed Human Cases for Avian Influenza A(H5N1) Reported to WHO, 2003-2024. World Health Organization. Retrieved 2024-05-07 from https://cdn.who.int/media/docs/defau...24_3&download= true

Return to footnote5referrer 6 Kandeil, A., Patton, C., Jones, J., Jeevan, T., Harrington, W., et al. (2023). Rapid Evolution of A(H5N1) Influenza Viruses after Intercontinental Spread to North America. Nature Communications, 14(1): 3082.

Return to footnote6referrer 7 Pulit-Penaloza, J. A., Brock, N., Pappas, C., Sun, X., Belser, J. A., et al. (2020). Characterization of Highly Pathogenic Avian Influenza H5Nx Viruses in the Ferret Model. Scientific Reports, 10(1): 12700.

Return to footnote7referrer 8 Cui, P., Shi, J., Wang, C., Zhang, Y., Xing, X., et al. (2022). Global Dissemination of H5N1 Influenza Viruses Bearing the Clade 2.3.4.4b HA Gene and Biologic Analysis of the Ones Detected in China. Emerging Microbes & Infections, 11(1): 1693-1704.

Return to footnote8referrer 9 Food and Agriculture Organization of the United Nations, World Health Organization, & World Organization for Animal Health. (2024). Joint FAO/WHO/WOAH Preliminary Assessment of Recent Influenza A(H5N1) Viruses. Retrieved 2024-05-06 from https://cdn.who.int/media/docs/defau...ba6_2&download =true

Return to footnote9referrer 10 The Center for Food Security & Public Health, Institute for International Cooperation in Animal Biologics, Iowa State University College of Veterinary Medicine, World Organisation for Animal Health, & United States Department of Agriculture. (2022). Highly Pathogenic Avian Influenza. The Center for Food Security & Public Health. Retrieved 2024-06-13 from https://www.cfsph.iastate.edu/Factsh..._influenza.pdf

Return to footnote10referrer 11 Charostad, J., Rezaei, Z. R. M., Mahmoudvand, S., Bashash, D., Hashemi, S. M. A., et al. (2023). A Comprehensive Review of Highly Pathogenic Avian Influenza (HPAI) H5N1: An Imminent Threat at Doorstep. Travel Medicine and Infectious Disease, 55: 102638.

Return to footnote11referrer 12 Public Health Agency of Canada. (2024). Rapid Risk Assessment Update: Avian influenza A(H5N1) Clade 2.3.4.4b in Livestock, Public Health Implications for Canada. Government of Canada. Available from https://www.canada.ca/en/public-heal...livestock.html

Return to footnote12referrer 13 World Health Organization. (2024). Influenza at the Human-Animal Interface Summary and Assessment, 28 March 2024. Retrieved 2024-05-07 from https://www.who.int/publications/m/i...-28-march-2024

Return to footnote13referrer 14 Herfst, S., Schrauwen, E. J., Linster, M., Chutinimitkul, S., de Wit, E., et al. (2012). Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science, 336(6088): 1534-1541.

Return to footnote14referrer 15 Human Pathogens and Toxins Act (S.C. 2009, c. 24).

Return to footnote15referrer 16 Health of Animals Act (S.C. 1990, c. 21).

Return to footnote16referrer 17 Government of Canada. (2022). Canadian Biosafety Standard (3rd ed.). Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...d-edition.html

Return to footnote17referrer 18 Government of Canada. Exclusions from the Human Pathogens and Toxins Act. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...oxins-act.html

Return to footnote18referrer 19 Government of Canada. Exemptions from the Licensing Requirements of the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...gulations.html

Return to footnote19referrer 20 Government of Canada. (2023). Biosecurity - Frequently Asked Questions. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...questions.html

Return to footnote20referrer 21 Government of Canada. (2021). Biosecurity. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...curity.html#a2

Return to footnote21referrer 22 Government of Canada. (2022). Service standards for sending out an acknowledgement letter for receipt of a Human Pathogen and Toxins Act Security Clearance application and the issuance of a Security Clearance. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...clearance.html

Return to footnote22referrer 23 Government of Canada. (2013). Protocol for Microbiological Investigations of Severe Acute Respiratory Infections (SARI). Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...ions-sari.html

Return to footnote23referrer 24 Government of Canada. (2024). Avian influenza A(H5N1): For health professionals. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...ionals.html#a9

Return to footnote24referrer 25 Government of Canada. (2024). Contact a Canadian Food Inspection Agency office by telephone. Ottawa, ON, Canada: Government of Canada. Available from https://inspection.canada.ca/en/abou...fice-telephone

Return to footnote25referrer 26 Government of Canada. (2024). Reportable diseases: Terrestrial animals. Ottawa, ON, Canada: Government of Canada. Available from https://inspection.canada.ca/en/anim...ses/reportable

Return to footnote26referrer 27 Government of Canada. (2023). Avian influenza (bird flu). Ottawa, ON, Canada: Government of Canada. Available from https://inspection.canada.ca/en/anim...vian-influenza

Return to footnote27referrer 28 Government of Canada. (2021). Canadian Biosafety Guideline—Human Diagnostic Activities. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...ctivities.html

Return to footnote28referrer 29 Government of Canada. (2018). Biosafety Directive for New and Emerging Influenza A Viruses. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...a-viruses.html

Return to footnote29referrer 30 Government of Canada. Guide to Services. Ottawa, ON, Canada: Government of Canada. Available from https://cnphi.canada.ca/gts/main

Return to footnote30referrer 31 Government of Canada. (2018). Canadian Biosafety Guideline—Local Risk Assessment. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...uidelines.html

Return to footnote31referrer 32 Government of Canada. (2023). Influenza A Virus Subtypes H5, H7, and H9: Infectious Substances Pathogen Safety Data Sheet. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...-h5-h7-h9.html

Return to footnote32referrer 33 Transportation of Dangerous Goods Act (S.C. 1992, c. 34).

Return to footnote33referrer 34 Canadian General Standards Board. (2021). CAN/CGSB-43.125-2021, Packaging of Category A and Category B Infectious Substances (Class 6.2) and Clinical, (Bio) Medical or Regulated Medical Waste. Ottawa, ON, Canada: Canadian General Standards Board. Available from https://publications.gc.ca/site/eng/...blication.html

Return to footnote34referrer 35 Transport Canada. (2024). Transportation of dangerous goods in Canada. Government of Canada. Available from https://tc.canada.ca/en/dangerous-go...s-goods-canada

Return to footnote35referrer 36 Transport Canada. (2022). Shipping Infectious Substances. Government of Canada. Available from https://tc.canada.ca/en/dangerous-go...ous-substances

Return to footnote36referrer 37 Government of Canada. (2017). About the Centre for Biosecurity. Government of Canada. Available from https://www.canada.ca/en/public-heal...osecurity.html

Return to footnote37referrer 38 Government of Canada. (2024). Licensing program. Ottawa, ON, Canada: Government of Canada. Available from https://www.canada.ca/en/public-heal...g-program.html

Return to footnote38referrer

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